Papillary Microcarcinoma of the ThyroidMITICANCT04129281
Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma
A study testing Surgery in people with Papillary Microcarcinoma of the Thyroid, run by National Cancer Institute, Naples at 1 site in Italy.
Trial summary
The primary objective of this study is to evaluate the outcome of two treatment approaches (immediate surgery or close follow-up) in patients with papillary thyroid microcarcinoma (mPTc) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papillary Microcarcinoma of the Thyroid
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 23 Jan 2019to 23 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >or =18
- Suspicious nodule < or = or 13 mm in the maximum size of thyroid ultrasound (not older than 3 months after the screening visit)
- Cytology consistent with the TIR4 or TIR 5 class
- Sieric TSH in th standard range (with or without levo-tyroxin therapy)
- Normal string motility to fibrolaringoscopy
- Written informed consent
Who cannot join
- Ultrasound evidence of suspicious lump located on the posterior side of the lobe close to neurogene structures
- Calcitonin increase above normal levels
- Clinical or instrumental evidence of locoregional lymph node metastases (central or laterocervical compartment) or remote
- any Contraindications to surgery
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istitute Nazionale Tumori - Fondazione G. Pascale
Naples
About this study
Official title: Prospective Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma
The primary objective of this study is to evaluate the outcome of two treatment approaches (immediate surgery or close follow-up) in patients with papillary thyroid microcarcinoma (mPTc) .
Read the detailed description
The primary objective of this study is to evaluate the outcome of two treatment approaches (immediate surgery or close follow-up) in patients with papillary thyroid microcarcinoma (mPTc) .
A further objective is to identify events associated with high risk of local recurrence and distant metastases.
Patients will be randomized to surgery or active surveillance. Patients who refuse the randomization process will be followed according to the treatment choice according to clinical practice.
- Conditions
- Papillary Microcarcinoma of the Thyroid
- Being tested
- Surgery
- Keywords
- Papillary Microcarcinoma of the Thyroid, Surgery, Outcome, Follow up
- Medical subject headings
- Papillary Thyroid Microcarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Surgery acconding to clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Other | Surgery Receives: Procedure: Surgery |
| Active surveillance | No intervention | Follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life in patient who received either surgery or follow up
EORTC QLQ-C30, a quality of life questionnaires, composed by 30 items graded from1 (not at all) to 4 (very much) within 1 year from the diagnosis
Measured: 36 months
Secondary outcomes (3)
Quality of life in patient who received either surgery or follow up
EORTC QLQ-C30, a quality of life questionnaires, composed by 30 items graded from1 (not at all) to 4 (very much) after 1 year from the diagnosis
Measured: 36 months
Compare the two strategies in terms of anxiety/depression
Evaluate the number of patients developing anxiety/depression (Hospital Anxiety and Depression Scale) (HADS scale, Each item on the questionnaire is scored from 0-3 and) in the two groups
Measured: 36 months
Compare the two strategies in terms of adverse events
Evaluate the number of patients developing adverse events (CTCAE 5.0)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start23 Jan 2019
- Primary completion23 Jan 2024 (estimated)
- Study completion23 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Microcarcinoma of the ThyroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to surgery or active surveillance. Patients who refuse the randomization process will be followed according to the treatment choice according to clinical practice.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luciano Pezzullo, Principal investigator, IRCCS Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129281
- Sponsor's protocol ID
- MITICA
- Acronym
- MITICA
- Status last verified
- Mar 2023
- First submitted
- 15 Oct 2019
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma
- ClinicalTrials.gov ID
- NCT04129281
- Acronym / sponsor ID
- MITICA / MITICA
- Conditions
- Papillary Microcarcinoma of the Thyroid
- Keywords
- Papillary Microcarcinoma of the Thyroid, Surgery, Outcome, Follow up
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 23 Jan 2024 (estimated)
- Study completion
- 23 Feb 2024 (estimated)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the outcome of two treatment approaches (immediate surgery or close follow-up) in patients with papillary thyroid microcarcinoma (mPTc) .
Detailed description
The primary objective of this study is to evaluate the outcome of two treatment approaches (immediate surgery or close follow-up) in patients with papillary thyroid microcarcinoma (mPTc) .
A further objective is to identify events associated with high risk of local recurrence and distant metastases.
Patients will be randomized to surgery or active surveillance. Patients who refuse the randomization process will be followed according to the treatment choice according to clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized to surgery or active surveillance. Patients who refuse the randomization process will be followed according to the treatment choice according to clinical practice.
| Arm | Type | Receives |
|---|---|---|
| Surgery | Other | Procedure: SurgerySurgery |
| Active surveillance | No intervention | –Follow up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >or =18
- Suspicious nodule < or = or 13 mm in the maximum size of thyroid ultrasound (not older than 3 months after the screening visit)
- Cytology consistent with the TIR4 or TIR 5 class
- Sieric TSH in th standard range (with or without levo-tyroxin therapy)
- Normal string motility to fibrolaringoscopy
Key exclusion criteria (4 listed)
- Ultrasound evidence of suspicious lump located on the posterior side of the lobe close to neurogene structures
- Calcitonin increase above normal levels
- Clinical or instrumental evidence of locoregional lymph node metastases (central or laterocervical compartment) or remote
- any Contraindications to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgerySurgery acconding to clinical practice | Procedure or surgery | Surgery |
Primary outcome
Quality of life in patient who received either surgery or follow up
Time frame: 36 months
EORTC QLQ-C30, a quality of life questionnaires, composed by 30 items graded from1 (not at all) to 4 (very much) within 1 year from the diagnosis
3 secondary outcomes
Quality of life in patient who received either surgery or follow up
Time frame: 36 months
Compare the two strategies in terms of anxiety/depression
Time frame: 36 months
Compare the two strategies in terms of adverse events
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciano Pezzullo principal investigator
IRCCS Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery in people with Papillary Microcarcinoma of the Thyroid, run by National Cancer Institute, Naples at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luciano Pezzullo (+39 0815903462, l.pezzullo@istitutotumori.na.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life in patient who received either surgery or follow up (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.